ISPE Hands-on Training: Impact of the Annex 1 Revisions
In Person, Deep Dive Training
Driven primarily by biopharmaceuticals but also important in small molecule drug product manufacturing and APIs, aseptic processing is undergoing a technology transformation driven by the new EC GMP Guide Annex 1. Companies globally that deliver medicinal products to Europe must comply with the new regulatory requirements. The Annex 1 revisions impact not only product manufacturers, but also engineering firms and equipment suppliers when providing services or equipment in either renovated or new production facilities.
The requirements of the new Annex 1 must be implemented in the production of sterile and aseptic processes. The industry is currently within the 1-year implementation period, and after the 24th of August 2023 manufacturers must fulfill the new Annex 1 requirements.
ISPE is offering a training program centered on how to implement these new requirements with a best practices approach. This training encompasses the two main pillars of the Annex 1: Quality Risk Management (QRM) and Contamination Control Strategy. In addition, this program covers aseptic production operations from compounding to fill & finish and freeze drying. The program consists of 2 full days at the Europe Aseptic and Sterile Environment (EASE) Training Center in Strasbourg, France. The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers.
For the 2-day sessions, ISPE will run four courses in parallel where the specific impacts of Annex 1 will be discussed.
- Advanced Therapy Medicinal Products (ATMPs) Manufacturing
- Commissioning & Qualification (C&Q)
- Heating, Ventilation, and Air Conditioning (HVAC)
- Pharmaceutical Water Systems
Visit EASE Training Center Industrial Platform for the Pharmaceutical Manufacturing (ease-training.fr) to learn how ISPE training courses coupled with hands-on activities at the EASE Training Center will benefit you in this interactive program. ISPE instructors are excited to welcome you to this training event in Strasbourg.
What to Expect?
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Production & QC area upstream
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Production & QC area upstream 2
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Production area for sterile liquids
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Production area for dry forms
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Air treatment system
Hands-On ATMP Manufacturing Training
22 - 23 Mar 2023
This new course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide. This course stays at the facility level and establishes guiding principles from the Good Practice Guides that should be considered during these emerging and rapidly evolving times.
ATMPs Manufacturing trainees will have the opportunity to enter graded clean rooms and interact with both single use as well as stainless steel equipment. Trainees will have the opportunity to discuss the advantages and disadvantages in practice for these manufacturing elements and understand the impact on facilities design.
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Hands-On Commissioning and Qualification Training
22 - 23 Mar 2023
This course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500. Includes a plant tour that focuses on providing context to the verbal training.
Commissioning and Qualification trainees will view the content of the qualification documentation of the EASE facility, which is fully qualified for pharmaceutical production. EASE staff will be available to explain their philosophy regarding the qualification work and documentation.
Bruce Davis, Director, Global Consulting, runs his own Company for training and consultancy in pharmaceutical science and risk-based approaches, including for example Quality risk management, Process Validation, qualification, GMP for Engineers, Technology Transfer. He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge. He has co-lead teams for several ISPE Good Practice Guides including Technology Transfer. He is an international trainer for ISPE in the above subjects, and has carried out training in EU, US, Japan and other countries in Asia-Pacific.
Hands-On HVAC & Environmental Control for Life Science Facilities Training
22 - 23 Mar 2023
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
HVAC trainees will have the opportunity to observe how the HVAC has been implemented in the EASE facility. They will spend time in the technical areas, learning how they have been designed, and understanding how to operate and maintain such a system.
Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Hands-On Pharmaceutical Water Systems Training
22 - 23 Mar 2023
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
Pharmaceutical Water System trainees will have access to water systems and clean utilities in the EASE facility. Trainees will discuss how to manage and operate such a system. Also, they will be able to visit the technical area and distribution loop, which will provide a complete understanding of a water system.
Stephan Neumann has a M.Sc. In Utility Engineering and is pursuing a M.Sc. in Pharmaceutical Microbiology. He started is professional career in 2000 in the biopharmaceutical industry. He works now for Boehringer Ingelheim since 2002 and his role is " Global Governance Pharmaceutical Water Systems". He is providing support to all production sites in the network. This encompasses hands-on site support, audit (response) support, troubleshooting, training, site improvements and much more. Stephan is a member of the ISPE D/A/CH Affiliate Expert Group on Water and Steam and the ISPE Critical Utility CoP Steering Committee, He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which describes multiple ways to produce WFI acc. to European regulations. He also was a chapter lead for the ISPE Good Practice Guide on "Membrane Based WFI systems" and ISPE Good Practice Guide on "Maintenance". At the moment he is co-chairing the revision of the ISPE Good Practice Guide on "Process Gases" Stephan is also a member of the EDQM Water Group. This group is responsible for the water monographies in the European Union.
Hands-On Aseptic Processing & Annex 1 Training
21 - 22 Jun 2023
The program consists of 2 full days at the Europe Aseptic and Sterile Environment (EASE) Training Center in Strasbourg, France. The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers. For this session, ISPE will conduct focused training on Aseptic Processing & Annex 1. Aseptic Processing & Annex 1 trainees will have the opportunity to enter graded clean rooms and interact with the single-use equipment as well as stainless steel equipment. Trainees will participate in fill & finish production under the direction of the EASE facility leaders. In addition, trainees will have the opportunity to discuss advantages/disadvantages in practice for all these elements and assess the impact on facilities design.
Upon completion of this course, trainees will be able to:
- Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
- Determine the current industry standards for manufacturing and environmental control
- Engage in critical topics discussion in regulators inspections
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Jörg Zimmermann is currently Vice President External Affairs for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he manages the relationships with regulatory agencies, professional organizations and other partners in the pharmaceutical industry. Before taking this role, he was responsible for Vetter Development Service which includes manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. Within Vetter, Jörg has held various positions in process implementation, new product introduction, lyophilization process development and as production manager before becoming Director of Production of Vetter's production site at Lake Constance in 2000. There he managed 5 production lines for aseptically prefilled injection systems. In September 2010 he became responsible for the process development and process introduction group at Vetter before being promoted to Vice President in November 2014.